Z-1607-2025 Class II Ongoing
FDA device recall Z-1607-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on March 3, 2025 and is designated Class II. Reason for recall: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
Reason for Recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Code Information
1) DYNJCD0339, UDI-DI: 10195327483753(each), 40195327483754(case), Lot Number: 24KBK055